2. 1. Prepare for production process
Objectives: At the end of this chapter you
will be able to:
Describe the importance of
extemporaneous compounding and
outline its process
Clean compounding areas and equipment
and maintain personal hygiene as per the
product requirements & procedure
Apply right dressing code as per the
product and institutional requirement
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3. Compounding
Compounding is the act of preparing,
mixing, assembling, packaging,
and/or labeling a drug or device as
the result of
a practitioner’s prescription drug
order or
initiative based on the practitioner–
patient–pharmacy professional
relationship or
for the purpose of research,
teaching, or chemical analysis
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3
4. Cont…
Extemporaneous
compounding Manufacturing
09/26/2022
4
is the timely preparation
of a drug product
according to
a physician’s
prescription
a drug formula or
a recipe in which
calculated amounts of
ingredients are made
into a homogenous
(uniform) mixture
is the production
promotion and
marketing of drugs
or devices
may start from
extraction
5. Importance of Extemporaneous
compounding
Reasons for Extemporaneous
Compounding include;
a. Unavailable dosages, strengths and
routes of commercial products
b. Dilution of adult doses of medications
to Pediatric/Geriatric strengths
c. Conversion of solid dosage forms to
solutions or suspensions
d. Combination of topical dermatological
products not available by the
manufacturer 09/26/2022
5
6. The compounding process
the compounder should adhere
strictly to procedures
compounder experience and
expertise are signifcant factors for
the production of safe and efective
formulations due to
diversity of the types and number of
preparations
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6
8. consideration during extemporaneous
compounding
Personal hygiene and protective
equipment
hands washed, ensuring any open cuts are
covered
Contact of hands with hair & mouth , biting
nails must be avoided
Use protective equipment as per
requirements
No canvas shoes, saddle shoes, open toe, or
sandals are allowed
Clean work area and equipment
09/26/2022
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9. Cont…
09/26/2022
9
Appropriate work area
Adequate lighting and ventilation
Label preparation
Prepare label before starting the
compounding procedure…this
eliminate the possibility of unlabeled
product will be left on the bench or
given to the wrong patient
Can be type written or computer
generated
10. The details, which must appear on the label of
a dispensed medicine
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10
The name and
address of the
pharmacy
The patient’s name
Name of the
preparation
Quantity of the
preparation
Formula of the
preparation (for
unofficial
preparations only)
The strength of the
preparation
Use of the preparation
Instructions for the
patient
The date of
compounding
Beyond used date
(shelf life)
Storage conditions
Additional label
( Precautions , Advise )
11. Special labeling instructions for particular
type of dosage form
Sr.
No.
Name of
preparation
Labeling instructions
1 Aerosol inhalation Pressurized containers keep away from
heat source.
Shake before use.
Do not exceed the prescribed dose follow
the instructions
2 Capsules Swallow with a draught of water
3 Creams For external use only, Store in a cool
place
4 Dusting powders For external use only
Not to be applied on open wound or to
raw or weeping surface.
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12. Cont…
6 Ear drops For external use only
7 Emulsions Shake the bottle before use
8 Enemas For rectal use only
Shake well before use
Warm to body temperature before use.
9 Eye drops To be used in 30 days after frst opening
10 Eye lotions To be used with 24 hrs after frst opening
11 Gargles and
mouth
washes
Not to be swallowed in large amounts
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13. Cont…
12 Granules To be dissolved or dispersed in water
before taking
13 Inhalation Shake the bottle before use
14 Nasal drops For nasal use only
15 Ointments For external use only
16 Paints For external use only
17 Pessaries for vaginal use only
store in cool place
18 Pastes For external use only
19 Solutions For external use only
20 Suppositori
es
For rectal use only
Store in a cool place
09/26/2022
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14. Cont…
21 Tablets
1. For soluble or dispersible tablets
Dissolve or dispensed
in water before taking
2. For chewable tablets Chew before
swallowing
3. For sustain release, Enteric coated
or unpleasant tasting tablets
Do not crush or chew
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15. The beyond-use date (BUD)
the date after which a compounded
preparation is not to be used
determined from the date of compounding
Compounders should consult and apply drug-
specifc and general stability documentation
and literature when available when assigning
BUD
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16. Cont…
For a non-sterile compounded preparations
of absent stability information and
appropriately stored; the following BUD are
assigned
For Non-aqueous Liquids and Solid
Formulations:
Where the compounded drug Product is the
source of Active ingredient-
BUD is not later than 25% of the time
remaining until the product’s expiration
date or
6 months, whichever is earlier 09/26/2022
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17. Cont…
For Water-Containing Formulations
(prepared from ingredients in solid
form):
BUD is not later than 14 days for liquid
preparations
For All Other Formulations:
BUD is not later than the intended duration of
therapy or 30 days, whichever is earlier
These beyond-use date limits may be
exceeded when there is supporting valid
scientifc stability information that is directly
applicable to the specifc preparation
(i.e., the same drug concentration range,
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18. Weighing and measuring procedure
During weighing to avoid any accidental cross-over
of ingredients
incorporate a weighed or measured ingredient into a
product immediately
If this is not possible, place each on a piece of
labeled paper
Premises standards
Premises’ decoration should be of a good basic
standard
floor- covered, smooth & cleanable
Sinks- have a supply of hot and cold water
Refrigerator – functioning & clean
There should be a supply of mains (potable) water
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20. Premises standards
The walls, floor ceilings, and floor of a
compounding laboratory shall be
smooth
have no cracks or holes
painted and/or made of washable material
The compounding room shall have adequate
light and ventilation (ventilator, etc.)
The compounding room should be protected
from direct sunlight
The window(s) of the compounding room
shall be high enough and sealed
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21. Avoidance of contamination
guidelines:
Ensure all equipment is clean and dry prior to
use
Keep the dispensing area clear of
unnecessary items
DO NOT
leave lids of stock bottles
return material to stock containers once
removed
leave weighed and measured items unlabeled
on the work surface
allow raw materials or the fnal product to
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22. Suitable record keeping
poor record keeping can lead to
dispensing errors
Therefore, the completion of the record
is safety check for the patient
Extemporaneous record sheets should
be kept for a minimum of two years
All records and reports should be readily
available in the pharmacy for
authorized inspection during the
retention period
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23. Compounding Process Recoding Form (Compounding sheet)
Name of the dispensary/health institution __________________________Date _______________
Batch number/control number_____________________________ Batch quantity______________
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Suitable record keeping
24. Storing or transporting the compounded product
Appropriate storage requires
environmental, security, and safety
considerations
Certain medications require freezing,
refrigeration, light-protection or room-
temperature conditions
Certain toxic chemicals should be kept
inside cabinets and kept low to the
ground
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25. General Procedures for Compounding
1. Receive, validate and interpret the prescription
as per the Standard Operating Procedures
(SOP) for dispensing
2. Ensure that the compounding area, equipments
and containers are ready for the process and
don’t compromise the quality of the fnal
product
3. Calculate the quantity of each ingredient
accurately
4. Weigh and measure the ingredients necessary
for compounding of the product as per the
procedures for weighing and measuring,
respectively 09/26/2022
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26. General Procedures for Compounding
7. Close the container and shake well as appropriate
8. Assign beyond-use date, prepare and attach a
proper label on the product container
9. Clean all the equipments used for the compounding
process and return to their original place
10. Clean the working table
11. Record the compounding process on the
Compounding Sheet
12. Dispense the product to the patient with proper
counseling
13. Record the prescription on the Compounding
Prescription Registration Book
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27. Equipments used in pharmaceutical compounding:
Mortars and pestles –two types
Glass –mortar and
pestle
Porcelain - mortar
and pestle
09/26/2022
27
very smooth surface
less suitable for size
reduction of powders
efficient when grinding
crystals into powder form
particularly useful when
dissolving small amounts
of medicament
Suitable for absorbable &
staining dyes e.g.
potassium permanganate
much larger than their
glass counterparts…used
for larger scale production
for the size reduction of
powders
for mixing powders with
other powders
for mixing powders with
liquids
for the preparation of
emulsions
28. Cont…
Tiles and spatula
used to prepare ointments by means
of trituration or levigation
Tiles are usually made of glazed
porcelain or glass
Spatula is used to pick solid or semi
solid ingredients & for levigation
09/26/2022
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29. Cont…
Stirring rods
used to agitate liquids to speed up the
process of dissolution of solids
between 20 and 30mm in length and made
of glass
Take care not to stir too vigorously to
prevent break
09/26/2022
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30. Cont…
Suppository moulds
Traditionally, suppository moulds come in a
range of sizes: 1 g, 2 g, 4 g and 8 g
These weights are nominal and imply
calibration with Theobroma Oil BP
For accurate calibration a mould would
need to be flled with base alone, the
individual suppositories formed weighed,
and the mean weight taken as the true
capacity
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31. Cont…
Water baths
Is a container flled with heated water
used to melt or heat reagents as
required
The item to be melted or heated is
placed in an evaporating basin over a
water bath containing hot water and
allowed to melt or get heated
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33. 09/26/2022
33
Watch glasses
is used as a surface
to evaporate a liquid
to hold solids while
being weighed
for heating a small
amount of
substance
as a cover for a
beaker
34. Measuring apparatus
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34
Made of glass or
plastic
used to measure
liquid
Several in type
Cylindrical
graduates
Conical
graduates
Beakers
Graduated
pipettes
Bottles
Burette
Dropper
37. Role of Pharmacy Technicians in Compounding
The securing of all prescribed medications or devices from
inventory
Measuring fnished dosage forms (known as “quality
sufficient” or “ q . s.”)
Collecting ingredients for preparations
Determining amounts of ingredients to be compounded
Compounding sterile preparations using appropriate aseptic
technique, equipment, and devices
Compounding cytotoxic or other hazardous preparations
Disposing of hazardous or non-hazardous waste materials
Packaging of fnished preparations
Generating accurate and complete labels and affixing them
appropriately
Storing all medications correctly prior to dispensing
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38. 2. QUALITY CONTROL IN
PHARMACEUTICAL COMPOUNDING
Introduction
Quality control and assurance is
designed to achieve
the utmost quality
purity
efectiveness
safety concerning drug products
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39. Quality Assurance (QA)
is all system which ensures activities involving:
Planning
quality control
quality assessment
reporting and
quality improvement
to ensure that a product or service meets
defned standards of quality with a stated
level of confdence
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40. Quality control (QC):
is overall system of activities concerned
with
Sampling
specifcation
testing
Organization
Documentation
release of procedure to ensure the
quality of the product
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41. GMP (Good Manufacturing
Practice
is part of quality assurance that
ensures products are consistently
produced and controlled to the
quality standard appropriate to their
intended use
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41
42. Relationships of QA, QC & GMP
GMP is a component of quality
assurance and QC is a component of
GMP Or
GMP and QC are components of quality
assurance
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42
43. Quality assurance principles
Q A is a wide-ranging concept covering all
matters that individually or collectively
influence the quality of a product
It is the totality of the arrangements made
with the objective of ensuring that
pharmaceutical products are of the quality
required for their intended use
Quality assurance therefore incorporates
GMP/GCP, QC and other factors, including
those outside the scope of this guide such
as product design and development
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44. The system of Q A should ensure that:
a. Pharmaceutical products are designed
and developed as requirements of
GMP/GCP and
other associated codes such as those of
good laboratory practice (GLP)
b. Production and control operations are
clearly specifed in a written form and
GMP/GCP requirements are adopted
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44
45. c. Managerial responsibilities are clearly
specifed in job descriptions
d. Arrangements are made for the
manufacture, supply and use of the
correct starting and packaging materials
e. All necessary controls on starting
materials, intermediate products, and
bulk products and other in-process
controls, calibrations, and validations
are carried out
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46. f. The fnished product is correctly
processed and checked, according
to the defned procedures
Pharmaceutical products are not
sold or supplied before the
authorized persons have certifed
that each production batch, produced
and controlled in accordance with the
requirements of the marketing
authorization
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46
47. g. Satisfactory arrangements should exist to
ensure the pharmaceutical products are stored,
distributed, and subsequently handled so that
quality is maintained throughout their shelf-life
There should be procedure for self-inspection
and/or quality audit that regularly appraises
the efectiveness and applicability of the
quality assurance system
h. Deviations are reported, investigated and
recorded
i. There is a system for approving changes that
may have an impact on product quality
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47
48. j. Regular evaluations of the quality of
pharmaceutical products should be
conducted with the objective of
verifying the consistency of the
process and ensuring its continuous
improvement
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49. Good compounding/manufacturing practices (GCP/GMP)
GCP/GMP is aimed primarily at
diminishing the risks inherent in any
pharmaceutical production
Such risks are essentially of two types:
1. cross contamination (unexpected
contaminants) and
2. mix-ups (confusion) caused by, for
example, false labels being put on
containers
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50. (GCP/GMP)…
Under GCP/GMP:
All compounding or manufacturing
processes are clearly defned,
systematically reviewed in the light
of experience
Qualifcation and validation are
performed
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51. (GCP/GMP)…
All necessary resources are
provided :-
I. qualifed and trained personnel
II. Adequate premises and space
III. Suitable equipment and services
IV. Appropriate materials, containers
and labels
V. Approved procedures and
instructions
VI. Suitable storage and transport
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52. (GCP/GMP)…
Instructions and procedures are written
in clear and unambiguous language
Operators are trained to carry out
procedures correctly
Records are made (manually and/or by
recording instruments) during
manufacture to show that all the steps
required by the defned procedures and
instructions have in fact been taken
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53. (GCP/GMP)…
Records of complete history of a batch to be
traced, are retained in a comprehensible and
accessible form
A system is available to recall any batch of
product from sale or supply
Complaints about marketed products are
examined
the causes of quality defects investigated,
and
appropriate measures taken in respect of the
defective products to prevent recurrence
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54. Continuous quality improvement
Before dispensing, the pharmacist should review
each step in the preparatory, compounding &
make fnal check
Aspects to be reviewed in quality control
include:
Appropriateness of ingredients, and equipments
used
correctness of calculations
Accuracy of measurements
Appropriateness of formulation for intended
use
stability limits of the preparation
09/26/2022
54
55. Cont…
The review of the fnal check is intended
to verify consistency with standard of:
The calculated yield is consistent with
the actual yield
The tolerance of variation
The physical characteristics (clarity,
color, and odor)
suitability of label & packaging
Documentation is appropriate
Adequacy of counseling
explicit storage and administration
09/26/2022
55
56. 3. OBTAIN AND PROCESS RAW
MATERIALS
Introduction
Drug substances are seldom administered
alone
Selective use of nonmedical agents, referred
to as pharmaceutical ingredients or
excipients, produces dosage forms of
various types
Drug = API (Active Pharmaceutical
Ingredient) + Non-API (Excipient)
Non-API: incorporated to aid some
physicochemical process of drug
manufacturing; has no pharmacological
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57. Commonly used pharmaceutical ingredients
09/26/2022
57
a. Pharmaceutical
solvents
b. Preservatives
c. Anti-oxidant
d. Bufers and pH
adjusting
agents
e. Viscosity
inducing agents
f. Emulsifying
g. Colorants
h. Flavorants and
Sweeteners
i. Disintegrants
j. Adhesives or
Binders
k. Diluents or
Fillers
58. Pharmaceutical solvents:
Dissolve another substance in preparation
selection depends on
knowledge of the chemical
characteristics of drugs
Solubility factors (size, Temperature, pH,
extent of agitation, Clarity, low toxicity,
viscosity, compatibility, chemical
inertness, palatability, odor, color, and
economy)
The most common solvent is water
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58
59. Preservatives:
Prevents the formulation from chemical,
physical and microbial degradation
E.g. Benzoic acid, boric acid, Sorbic acid,
Benzalkonium Chloride, Phenols, Alcohols
Anti-oxidant:
Prevent the degradation of a drug by oxidation
Have higher oxidative potential or
inhibit free radical-induced drug decomposition
Employed in low concentrations (<0.2%w/w)
E.g. Ascorbic acid, sodium bisulfate, sodium
formaldehyde, sodium meta bisulfte
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59
60. Bufers and pH adjusting agents:
A bufer resists changes in PH
It is composed of a weak acid and its conjugate
base or a weak base and its conjugate acid
adjust it upon addition of an acid or base to:
Bufers are added as pharmaceutical ingredient
to:
Increase comfort to the site of administration
Render the formulation more stable
Enhance the aqueous solubility of the drug
Enhance the drug’s bioavailability
Maximize preservative efficacy
E.g. Potassium meta phosphate, Potassium
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61. Viscosity inducing agents:
Render resistance to flow for Suspensions,
ophthalmic solutions, topical creams and oral
solutions
E.g. Alginic acid, Bentonite, Carbomer, sodium
carboxy methyl cellulose, Sodium alginate,
Tragacanth, glycerol etc
Emulsifying agents and Surfactant:
Promote and maintain dispersion of liquid in
another liquid in which it is immiscible
(Suspension and emulsion)
E.g. Tragacanth, Bentonite, Polysorbate 80,
Accacia,
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62. Colorants:
Colorants are added to impart color
to liquid and solid preparations
For esthetics and patient compliance
For identifcation & to minimize the
medication errors
E.g. Titanium dioxide, Calamine, Azo
dye, Nitroso dyes, xanthenes, Nitro
dyes
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62
63. Flavorants and Sweeteners:
Flavorants- impart a pleasant flavor
Sweeteners- Impart sweetness to the
preparation
E.g. Aspartame, Dextrose, Glycerin, Mannitol,
Saccharin sodium, Sorbitol, Sucrose
Disintegrants:
Overcome the cohesiveness imparted during
compression
It increases break up → increase surface area →
increase dissolution → increase absorption
Eg. Starch, Alginic acid, Polacrilin potassium,
Sodium alginate, Microcrystalline cellulose
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64. Lubricants:
Reduce friction during tablet
compression
Enhance the flow of the material
Minimize wear of the part of the
machines
Prevent fll material from sticking
Produce tablets with sheen
E.g. Fine silica, magnesium stearate,
Talc
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64
65. Adhesives or Binders:
Promote adhesion in Granules and
tablets
E.g. Acacia, Alginic acid,
Carboxymethylcellulose sodium,
Compressible sugar, Ethylcellulose,
Gelatin, Liquid glucose,
Methylcellulose, Povidone,
Pregelatinized starch, dibasic calcium
phosphate, polyvinyl pyrollidine.
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66. Other pharmaceutical ingredients:
Ointment bases-Parts of an ointment which
is used as a Vehicle
Suppository bases-Vehicles for
suppositories
Gelling agents-They are ingredients that
give the preparation a gel like consistency
e.g.: Tragacanth- bassorin pastes, Sodium
alginate, Pectin, Starch
Diluents or Fillers: Create tablet of proper
size and consistency
Quantity of active ingredient is small or
difficult to compress so that diluents and
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67. Packaging and pre-pack of pharmaceutical
products
Packaging is the science, art and technology
of enclosing or protecting products for
distribution, storage, sale and use
Pharmaceutical Packaging is an economical
means of providing
Protection
Identifcation/information
Containment
convenience and compliance for a drug
product during storage, carriage, display and
use until its day of expiry
09/26/2022
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68. Cont…
packaging standards required to comply
with requirements, such as
efficacy, integrity, purity, safety,
and stability
For these reasons packaging technology
should be based on understanding of:
characteristics of formulations,
dosage forms
physical and chemical properties of the
drug substance
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68
69. Cont…
Packaging involves various types or
categories of containers.
A container is defned as “that which
holds the article and is or may be in
direct contact with the article”.
The closure is “a part of the
container”
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69
70. Desirable qualities of a container
Protect the contents from physical
and mechanical hazards. i.e.
Vibration, compression, shock,
abrasion, punctures etc.
No reaction with the content
Should not release any chemical
No adsorption of the product
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71. Should not impart taste or odors and
not shed the particles
Should be nontoxic
Should give convenient and easy with
drawl of the required dose
Be capable of withstanding extremes
of temperature and humidity
Protect the contents from both water
loss and gain
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72. Protect the content from loss of volatile
materials.
Be sufficiently transparent to permit the
inspection of the content
This may be impractical for drugs sensitive to
light
Be easy to label and thus to identify the
product
Be cheap and economical
Adoptable to certain high speed flling
equipment
09/26/2022
72
73. The purposes of packaging and package
labels
Protection: most critical factor as it
controls the total shelf-life of the product
Physical protection
Barrier protection - A barrier from
oxygen, water vapor, dust, etc., is often
required
Permeation is a critical factor in design
Some packages contain desiccants or
oxygen absorbers to help extend shelf life
09/26/2022
73
74. Cont…
Containment or agglomeration - E.g.
Liquids, powders, and granular materials need
containment
Information transmission
to encourage marketing
Security- Packages can be made with
improved
tamper resistance
pilferage resistance -electronic article
surveillance tags that can be activated or
detected by devices at exit points
09/26/2022
74
75. Cont…
Convenience - in distribution,
handling, stacking, display, sale,
opening, reclosing, use, dispensing
and reuse
Offer consumer safety: -warn of
hazards
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76. Packaging Types
Based on the type of product
packaged:
medical device packaging
bulk chemical packaging
pharmaceutical packaging etc
Based on layer or function:
Primary
Secondary
tertiary
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77. A primary pack (container)
directly in contact with the product
(e.g. bottle, cap)
main functions- to contain and
restrict any chemical, climatic,
biological or occasionally mechanical
hazards
-pack of 'use‘- means of drug
administration
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77
78. can be made of glass, plastic, single
or laminated flexible material and
metal
Examples of primary packaging
materials include:- Containers,
Ampoules, Vials, Dosing dropper,
Closures (plastic, metal), Syringe,
Strip package, Blister packaging
09/26/2022
78
80. ii. Secondary packaging
not in direct contact with the product
include an over-pack, over-wrap or pouch
provide moisture, gas, light or microbial
protection that is not provided by the primary
container
may be used for the fnal market presentation
often used to carry the required labeling for
the product
can provide protection against damage in the
handling and distribution system
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80
82. iii. Tertiary packaging
used for bulk handling, warehouse
storage and transport shipping.
The most common form is a
palletized unit load that packs tightly
into containers
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82
84. USP classifcation of containers
based on their ability to protect their
contents from external conditions
A well-closed container: protects
from extraneous solids and from loss
under ordinary conditions of
handling, shipment, storage and
distribution
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85. A tight container: protects the
contents from
contamination by extraneous liquids,
solids or vapors
from loss of the article
from eforescence
Deliquescence
evaporation
is capable of tight re-closure
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85
86. Hermetic sealed containers:
impervious to air or any other gas under
pharmaceutical preparations
Sterile hermetic containers generally hold
parenteral preparations
may be:
Single dose containers - fusion sealed
-cannot be resealed
e.g. ampoules and preflled syringes and
cartridges
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87. Multi dose container- commonly called
vials
A light–resistant container: protects the
contents from the efects of light
by virtue of the specifc properties of the
material of which it is composed
clear and colorless or translucent container
of opaque covering
by adding ultraviolet absorbing agents to
plastic to decrease the transmission of short
ultraviolet rays
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88. Tamper evident containers: ftted
with a device that irreversibly
indicates if the container has been
opened
Child resistant containers: one
that is signifcantly difficult for
children under 5 years of age to open
or to obtain a harmful amount of its
contents within a reasonable time
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88
89. Strip packs: have at least one
sealed pocket of material
That each pocket containing a single
dose of the product
They are common ways of unit
packaging of a solid drug formulation.
The packaging materials may be
combinations of paper, foil, plastic, or
cellophane
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90. Pressurized packs (aerosol
containers): expel the product
through a valve
Original packs are pharmaceutical
packs that are commercially produced
and intended for fnite treatment
periods
Better to dispense medication in the
same type and quality of container as
that used by the manufacturer
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90
91. Inventory control
Role of the pharmacy Technician in
Inventory control
Following the policies and procedures of
inventory control
Providing accurate inventory records
Determining sources of pharmaceutical
products
Identifying and ordering needed
pharmaceutical products
Receiving and storing pharmaceutical
products
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92. Procedures for ordering and
receiving raw materials
Receiving
follow the pharmacy’s procedures for
receiving raw materials
The supplier includes an invoice, which is a
listing of the items
Checked item against invoice to make sure
that nothing is missing, and un ordered is
included
document the receipt of goods by entering the
information into a computer, or by scanning
bar codes.
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93. Returning Items
After checking all items against the orders
that you receive, return
Defective
Expired
more than needed items using return form
Information's that must be included on a
return form:
Original purchase order (P.O.) number
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94. Item number
Quantity
Reason for return
Similar procedures are followed for obtaining
and returning raw materials for compounding.
IFRR form is used for this purpose
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95. COMPOUNDING EXTEMPORANEOUS
PRODUCTS
Objectives : to
Discuss diferent Compounding
methods
Explain Storage conditions of
compounded products
Apply appropriate Beyond use dates
on labels
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96. Compounding methods
Compounding of pharmaceutical
solutions
A solution- is a thermodynamically stable
Homogeneous/one-phase system/composed
of two or more components
one of which is completely dissolved in the
other
pharmaceutical solutions are composed of
a solid, liquid, or gas dissolved in a liquid
solvent
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97. Cont…
Solute- is the component present in the
smallest amount e.g.AI, flavoring or
coloring agents, preservatives, and
stabilizers or bufering salts
solvent is the larger, liquid component
E.g. -water, ethanol, glycerin, alcohol
-aromatic waters, glycerol, syrup,
-propylene glycol, isopropyl
alcohol, etc.
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98. appropriate solvent:-
completely dissolve the drug and
other solid ingredients
be nontoxic and safe for ingestion or
topical application
be aesthetically acceptable to the
patient in terms of appearance,
aroma, texture, and/or taste
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99. Water is the vehicle of choice for the
majority of pharmaceutical solution
because
Available
relatively inexpensive
Palatable
non- toxic for oral use
non-irritant for external use
compatible with wide range of
substances
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100. Types of solutions
1. Solution taken orally: mixtures,
elixirs, syrups, linctuses, draughts
2. Solution used in mouth and throat:
- mouth washes and gargles, throat
paints, throat sprays
3. Solution instilled into body
cavities: douches, enemas, eardrops,
eyes drops, nasal drops, nasal sprays
4. Solution applied to body surface:
collodions, liniments, lotion and paints
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101. General Method of preparation of Solution
1. Write out the working formula either
from the prescription (unofficial) or
from an official text (official)
2. Calculate the quantities required for
each ingredient in the formula to
produce the required fnal volume
3. Complete all sections of the product
worksheet
4. Prepare a suitable label
5. Weigh all solids
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102. Cont…
6. Identify the soluble solids and
calculate the quantity of vehicle
required to dissolve the solids fully
If more than one solid is to be
dissolved, they are dissolved one by
one,
the least soluble frst
dissolve in a glass /plastic/ beaker,
not a conical measure
solubility of the soluble solids will be
dependent on the vehicle used
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103. Cont…
7. Transfer the appropriate amount of
vehicle to a glass beaker
8. If necessary, transfer the solid to a
glass mortar and use the glass pestle
to reduce particle size to aid
dissolution
9. Transfer the solid to the beaker and
stir to aid dissolution, rinse mortar if
used with a little vehicle
10.When all the solid(s) has/have
dissolved, transfer the solution to the
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104. Cont…
11.Rinse out the beaker in which the
solution was
made with a portion of the vehicle,
and transfer the rinsing’s to the
conical measure.
12.Add any remaining liquid ingredients
to the conical measure and stir
13.Make up to fnal volume with
remaining vehicle
14.Transfer to a suitable container, label
and
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105. Aromatic water
Aromatic waters are aqueous solutions
usually saturated of volatile oils or
other volatile substances that are
characterized by very low water
solubility- E.g. Chloroform
Aromatic waters are used externally
as perfumes (e.g. Rose water)
Internally- as flavoring agents
peppermint water, cinnamon water
-used as carminative
chloroform water -used in expectorant
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106. Spirits
are alcoholic or aqueous alcoholic solutions
of volatile substances
Like the aromatic water the active
ingredients in the sprits may be a solid,
liquid or gas
The volatile substance in the majority of
case is volatile oils
Some used internally/by inhalation medically
But a large number are used as flavoring
agents
Spirits should be kept in well-closed
containers and stored at temperature not
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107. Tinctures
alcoholic or hydro alcoholic solution
extracted from natural sources or of pure
chemical(e.g. iodine tincture) merely dissolved
in these solvent systems
Tinctures vary widely in
method of preparation
the strength of their volatile ingredients
alcoholic content
intended use
Tinctures are prepared by a number of
processes:
maceration (process M); percolation (process
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108. Syrups
concentrated aqueous solutions of
sucrose, other sugars or sweetening
agents
small quantities of suitable polyhydric
alcohols may be added to retard
crystallization or to increase the
solubility of the other ingredients
Syrups usually contain aromatic or
other flavoring materials
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109. Elixirs
is a liquid oral preparation that usually
contains either potent or unpleasant-
tasting drugs
The formulation is clear and generally
contains a high proportion of sugar or
other sweetening agent, included to
mask ofensive or nauseating tastes.
Pediatric elixirs are usually formulated
with fruit syrup as a base flavoring
agent
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110. Linctuses
is a liquid oral preparation that is
chiefly used for
a demulcent
expectorant
sedative purpose
Principally used in the treatment of
cough
A linctus is intended to be sipped
slowly and allowed to trickledown the
throat in an undiluted form 09/26/2022
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111. Suspension
Suspension - dispersed systems in which
fnely divided drug practices (called the
disperse phase) are distributed thought
out a vehicle (called dispersion medium or
continues phase)
in which the drug exhibits a minimum
degree of solubility.
include powders in dry from to be place in
suspension and drugs suspended in liquid
vehicles
Major applications: 09/26/2022
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112. General methods of preparation of suspension
1. Carefully tare(calibrate) the container to
the required volume
2. Finely powder any solid ingredient not
already in fne powder
3. Mix the insoluble powders in a mortar
adding ingredients in order of increasing
of bulk using amounts approximately
equal to bulk already in the mortar
(geometric dilution)
4. Add enough vehicles to produce a smooth
paste 09/26/2022
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113. Cont…
6. Dilute with a vehicle until pourable
Examine the suspension critically and
if it contains foreign particle strain
through muslin
7. Transfer it to the tarred bottle
8. Add any volatile solid ingredients
previously dissolved in some of the
vehicle and mix well
9. Add any liquid ingredients raise the
measures and mix well after each
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114. Cont…
10.Rinse the mortar and pestle with
successive volumes of the vehicle
until they are quite clean transferring
the rinsing to the bottle
11.Make up to volume with the vehicle
and shake thoroughly
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115. Compounding of Emulsions
An emulsion is a disperse system
consisting of two immiscible liquids,
usually water and oil, as small globules
Since this type of dispersion is
inherently unstable, the system is
stabilized by the presence a third
component, the emulsifying agent
(emulgent, emulsifer)
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116. Determination of Emulsion Type
Emulsions could be oil in water (O/W) or water in
oil (W/O) in type
Tests for distinguishing between O/W and W/O
emulsions include:
1. Dilution Test (Miscibility Test): dilution of an
emulsion with water or oil
2. Dye-solubility Test (Staining Test): use of
dyes soluble only in either the aqueous or the
oil phase of an emulsion, but not in both
phases, e.g. Scarlet red, Sudan III
3. Conductivity Test: O/W emulsion possesses a
much higher conductivity than W/O emulsion
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117. Stability of Emulsions
A stable emulsion is one in which the
globules retain their initial character
(i.e., mean size and size distribution)
Remain uniformly distributed
throughout the continuous phase
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118. Instability in emulsion includes
1. Cracking (Breaking) coalescence of the
dispersed globules and separation of the
disperse Phase as a separate layer
simple mixing fails to re-establish the
stable emulsion
2. Creaming-the formation of a layer of
relativel concentrated emulsion
less serious than cracking because a
creamed emulsion may be made homogenous
again by shaking
Large droplets cream more rapidly-
eventually crack 09/26/2022
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119. Small-Scale Preparation of
Emulsion
can be prepared using a mortar and
pestle
efficiency is limited and the globule
size may be larger than 10μm
Electric Mixer may be used on a small
scale
entrapped air may be a problem
quality and stability of the product can
be improved by
decreasing globule size
use of homogenizers 09/26/2022
119
120. Cont…
A. Mortar and pestle:
for emulsions that are stabilized by the
presence of a multimolecular flm (e.g.,
Acacia, tragacanth and agar) at the
interface
There are two basic methods
i) The Wet Gum (or called English) Method
the emulsifying agent is placed in the
mortar and dispersed in water to form
mucilage
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121. Cont…
The oil is added in small amounts with
continuous trituration,
each portion of the oil being emulsifed
before adding the next increment
ii) The Dry Gum (or called continental)
Method
In this method, the gum is added to the
oil
preferred by most pharmacists
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122. Cont…
Acacia Emulsions
extemporaneously prepared emulsions for
internal use are made with acacia gum, unless
specifed
To prepare acacia emulsions using a pestle and
mortar:
a thick (primary) emulsion must be made frst
quantities for primary emulsions- determined by
experience
Parts by volume is parts for fxed, mineral,
and volatile oils
part by weight for oleoresins and acacia
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123. Cont…
In both the Dry Gum and the Wet
Gum methods
a primary or concentrated emulsion is
frst prepared using a set ratio of oil,
water, and gum (emulsifying agent)
then the fnal product is obtained by
dilution with the continuous phase
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124. Quantities for Primary
Emulsions
Types of
oil
Examples Quantities for primary emulsions (Parts)
Fixed oil Almond oil oil Water Gum
(Acacia)
Tragacant
h
Arachis oil 4 2 1 0.1
Castor oil
Cod-liver
oil
Mineral oil Liquid
paraffin
3 2 1 0.1
Volatile oil Turpentine
oil
2 2 1 0.1
Cinnamon
oil
Peppermint
oil
Oleo-resin Male fern
extract
1 2 1 0.1
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125. The amount of trangacanth needed is
only one-tenth of the acacia amount
When an emulsion contains two or
more oily liquids the quantity of
acacia for each is calculated
separately and the sum of these
quantities used
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126. The method is as follows:
1. Measure the oil very accurately in a dry
measure:
pour it into the bottom of a large,
perfectly dry, flat bottomed mortar
allow the measure to drain by resting
2. measure the quantity of water or
aqueous vehicle required for the
primary emulsion and place this within
easy reach
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127. 3. Weigh the acacia powder
4. Remove the oily measure from the mortar:
place the gum on the oil and mix lightly
for just long enough to disperse
Take care to keep the suspension in the
bottom of the mortar, Do not over mix
5. Immediately add all the previously
measured water and stir continuously but
lightly in one direction until the mixture
thickens
Then Stir and mix vigorously in the mortar
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128. 6. When the primary emulsion is well formed there
is usually a characteristic ‘Cracking’ sound
Continue to triturate for a further 2-3 minutes to
produce a white, stable emulsion
The fner the dispersion the whiter the product
7. Gradually dilute the primary emulsion with small
volumes of the vehicle ensuring complete mixing
between additions
8. Transfer to a measure and make up to fnal
volume
9. If necessary, decant through a muslin strainer
into a calibrated bottle
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129. Problems:
Sometimes the primary emulsion does
not form properly and the contents of
the mortar become oily, thin and
translucent
This is due to phase inversion, the
product, which has become a W/O
emulsion cannot be diluted with water
and must therefore be discarded.
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130. Possible causes of the problem are:
Insufficient shear between the mortar
base and the pestle head
Inaccurate measurement of water or oil
Cross contamination of water or oil
Excessive mixing of oil and gum
Too early or too rapid dilution of the
primary emulsion
Poor quality acacia
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131. B. Other Methods
An increasing number of emulsions are
being formulated with synthetic
emulsifying agents, especially of the
non-ionic type
When using many of these highly
active synthetic agents, it is possible to
obtain excellent preparations by simply
adding the warmed phases to a
beaker and stirring until cool.
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132. In place of a beaker, the phases can
sometimes be placed into a bottle,
which is then shaken.
With hand homogenizers an initial
rough emulsion is formed by titration
in a mortar or shaking in a bottle.
The rough emulsion is then passed
several times through the
homogenizer
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133. Containers and Labeling
Emulsions should be supplied in well-
flled containers with airtight closures
For viscous preparations wide-
mouthed amber glass bottles are
most appropriate
Labeling: shake the bottle, store in
cool place but avoid freezing
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134. Compounding of Semisolid dosage forms
Ointments
are semisolid preparations intended for
external application to the skin or
mucous membranes
may be medicated or non- medicated
(ointment bases)
ointment bases-used as emollient or
lubricant efect, as vehicles in
preparation of medicated ointments
four main classes of ointment bases
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135. classes of ointment bases
Hydrocarbon bases:- composed of
oleaginous compounds having low
water content and hydrophobic
On application to the skin
have an emollient efect
protect against the escape of moisture
efective as occlusive dressings
remain on the skin for long periods
without drying out
difficult to wash of -immiscible with
water 09/26/2022
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136. Cont…
Absorption bases:- hydrophilic
anhydrous materials-absorb water to
become W/O emulsions
hydrous bases- W/O emulsions that
have the ability to absorb additional
water
Examples: hydrophilic petrolatum and
anhydrous lanolin
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136
137. Cont…
Water-miscible bases:- O/W emulsion
bases/creams
most commonly used type of ointment base
washable and removed easily from skin or
clothing
Example: Hydrophilic Ointment, USP
Water soluble bases:- made up of soluble
components or may include gelled aqueous
solutions
Example: Polyethylene glycol (PEG) ointment
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138. Preparation of ointments
Two techniques are used in mixing
ointments
a) Mixing by fusion
On a small scale, fusion is usually carried
out in an evaporating basin water bath
Fusion is necessary when waxes, hard
paraffin, fatty alcohols, fatty acids or any
hard wax- like material is included in the
formula
Fusion is used also when a medicament is
soluble in the melted base
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139. b) Mixing by trituration
This method is applicable when the
medicament is a solid insoluble in the
bases or liquid present in small
amount
Trituration may be carried out with an
ointment tile and spatula or using a
mortar and pestle
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140. Packaging and Storage of ointments
Ointments are dispensed in either
ointment tube or collapsible tube
However, ointments prepared
extemporaneously are usually packed in
ointment jar
should be stored in a cool place
Insoluble medicament may settle to the
bottom of the container if the ointment is
permit to liquefy
Excessive heat or cold may cause an
emulsion base to separate into two phases
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141. Pastes
ointment-like preparations intended for external
application
contain large amounts of fnely powdered solids thus
stifer than ointments
less greasy and more absorptive
They are applied generously, either with a spatula or
spread on lint or other dressing and
not removed for long periods
pastes are prepared in the same manner as ointments
Pastes are generally packed in glass ointment jars
They are often too viscous for easy extrusion from
tubes
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142. Gels
Jellies are transparent or translucent,
non-greasy semisolid
generally applied externally
Jellies are used for medication
(Medicated jellies), lubrication
(Lubricating jellies) and some
miscellaneous applications
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143. Formulation of Gels
Gelling agents are usually organic
hydrocolloids but, occasionally,
hydrophilic inorganic substances
Organic hydrocolloids: Tragacanth,
Sodium alginate, Pectin, Starch,
Gelatin, Cellulose derivatives
(Methylcellulose, Sodium
carboxymethylcellulose,
Hydrroxypropyl methylcellulose),
Carbomer, Polyvinyl alcohols, and
others 09/26/2022
143
144. Cont…
Other additives for gels
Humectants- substance used to reduce the loss of
moisture from the preparation-prevent coarsening of
the matrix
Example:- glycerol, propylene glycol or Sorbitol Solution
Preservatives: Gels have high water content; thus
liable to microbial growth…preservative is added
Chelating agents: are ingredients that bind with
metal ions or metallic compounds
preventing contamination or discoloration Bases and
medicaments sensitive to heavy metals are
sometimes protected by chelating agents such as
EDTA
09/26/2022
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145. Cont…
Packaging
Lubricating jellies should be packed in
collapsible tubes
However, stifer gels for application to
the skin-in ointment jars
Containers should be well flled and
airtight to prevent evaporation
Storage
Jellies should be stored in a cool place
to prevent loss of water via evaporation
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146. General method of compounding gels
1. Heat all components of the gel (with
the exception of water) to
approximately 90°C
2. Heat water to approximately 90°C
3. Add water to oil, stirring
continuously
Avoid vigorous stirring as this will
introduce bubbles
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147. Creams
viscous semi-solid emulsions for external use
Medicaments can be dissolved or suspended in
creams
A cream may be ‘water-in-oil’ or ‘oil-in-water’
depending on the emulsifying agent used
A cream is always miscible with its continuous
phase
Creams may contain one or more medicaments
in solution in one or other of the phases
Finely powdered insoluble medicaments may
also be dispersed in a cream base
09/26/2022
147
148. Cont…
Water-in-oil creams (oily creams) as bases
produced by the emulsifying agents of natural
origin (e.g. beeswax, wool alcohols or wool fat)
Oil-in-water creams (aqueous creams) as
bases
produced by the synthetic waxes
(e.g.macrogol and cetomacrogol)
They are the best bases to use for rapid
absorption and penetration of drugs
They are thin, white and smooth inconsistency
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149. Preparation of creams
The components of the oily phase (usually including the
emulgent) are heated until molten and the temperature
rises to 75ºC
The components of the aqueous phase are mixed in a
separate vessel and also heated to 75ºC
The aqueous phase is then added to the oily phase at the
same temperature and the resulting emulsion is stirred
gently until cool
Thermometer should be used to control the temperatures
of the two phases
Rapid cooling may result in separation of high melting
point components
Excessive aeration caused by vigorous stirring may also
lead to a granular product
09/26/2022
149
150. Cont…
Packaging
Wide-mouthed jars may be used for creams
where the risk of contamination in use is
considered to be minimal, e.g. oily creams
otherwise collapsible metal or flexible plastic
tubes
The containers must be well closed and
prevent water evaporation
The mouth of the jar should be covered with
a disc of greaseproof paper
Storage
Creams should be stored in a cool place but
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151. Compounding of Powders
Powders are solid preparations intended
for either internal or external use
The following types of preparation will
be considered:
Bulk powders for external use (dusting
powders):- dry, free-flowing
preparations consisting of one or a
mixture of fnely powdered substances
and intended for external application
Bulk oral powders:- resemble dusting
powders with the exception that they
09/26/2022
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152. Cont…
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152
Divided (Individual unit dose) Powders:-
contain one or more active ingredients
together with an inert diluents to produce
minimum quantity that can be weighed
by the dispenser and handled by the
patient
folded in powder papers after
preparation
waxed (waterproof) paper for hygroscopic,
deliquescent or volatile ingredient
containing powders
153. Compounding method of powders
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The basic techniques are
weighing
Size Reduction
Mixing using the geometric dilution
method
On a small scale the powdered
ingredients may be mixed with a
mortar and pestle
